CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT
HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
CONFIDENTIAL TREATMENT
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement is entered into effective as of Tuesday
March 6th, 2003, by and between INyX Pharma Ltd., a company organized under the
laws of England and Wales ("INyX"), and Xxxxxxx Laboratories, Inc., a New York
corporation (the "Customer").
BACKGROUND
A. The Customer desires to use INyX's facilities, resources and expertise to
manufacture the Products, as defined below, and INyX desires to act as a
contract manufacturer of the Product(s) agreed to by both Parties in accordance
with the terms and conditions set forth in this Agreement;
B. INyX and the Customer wish to enter into this manufacturing and supply
agreement on the terms and conditions set forth in this Agreement, for the
consideration set forth in this Agreement.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants
set forth below, INyX and the Customer agree as follows:
AGREEMENT
ARTICLE 1
DEFINITIONS
-----------
For the purposes of this Agreement, the following capitalized terms shall have
the following meanings:
"Affiliate" means any corporation or other business entity controlled by,
controlling or under common control with a Party hereto. For this purpose
"control" shall mean direct or indirect beneficial ownership of fifty percent
(50%) or more of the voting stock, or a fifty percent (50%) or more interest in
the income of, such corporation or other business entity.
"Batch" shall have the meaning set forth in the Quality Agreement.
"Certificate of Analysis" means a summary of the quality control testing, as
described in the Product Specifications, performed by INyX for Finished Product
supplied under this Agreement.
"Change" shall have the meaning set forth in the Quality Agreement.
"Commercially Reasonable Efforts" means, with respect to a Party, the efforts of
such Party that are reasonable in light of the size of the present and potential
markets for the Products (as reasonably determined by such Party) and consistent
with such Party's efforts used in similar activities regarding other products of
similar market potential.
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"Confidential Information" shall have the meaning set forth in Section 7.3 of
this Agreement.
"Customer Representative" means the person designated by the Customer who shall
be primarily resident on site at INyX's facility. As of the date of this
Agreement, * * * is designated as the Customer Representative.
"Date of Manufacture" shall have the meaning set forth in the Quality Agreement.
"Dermatological Products" shall have the meaning set forth in Section 4.3.
"Development Agreement" means any separate agreement entered into by the Parties
with respect to a potential Product that is not yet ready to be manufactured on
a commercial scale, including the requirements surrounding production of units
of Product and Placebo appropriately labeled for use in the Customer's clinical
trials (in amounts to be specified by the Customer, as required). Each such
Development Agreement shall, when executed, be appended to this Agreement as an
Exhibit E.
"DMF" means the Drug Master File for a Product, as filed by INyX with the FDA.
"FDA" means the Food and Drug Administration of the United States of America.
"Finished Product" shall have the meaning set forth in the Quality Agreement.
"IND" means an Investigational New Drug Application for a Product, as filed by
the Customer with the FDA.
"INyX" means INyX Pharma Ltd.
"Initial Term" shall have the meaning set forth in Section 10.1.
"Labeling" means the primary container label, secondary packaging, package
insert, shelf pack and shipper label specific to a finished Product manufactured
in accordance with cGMPs and the Customer's instructions.
"Losses" shall have the meaning set forth in Section 11.1.
"Manufacturing Standards" means the specifications for manufacturing, packaging,
labeling and storing the Products set forth in the Product Specifications, the
master batch record, cGMPs, MSDSs, and all other applicable U.S. laws and
regulations.
"MSDS" means material safety data sheets.
"NDA" means a New Drug Application for a Product, as filed by the Customer with,
and approved by the FDA.
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"Party" means INyX or the Customer and "Parties" means both INyX and the
Customer, as the context requires.
"Placebo" means a Product adjusted to be formulated without the active
ingredient.
"Product Specifications" means the specifications provided by the Customer in
writing for the manufacture of any Product and accepted by INyX from time to
time, and includes all such specifications as may be required pursuant to
applicable regulatory laws.
"Product(s)" means Dermatological Products and the products described on Exhibit
A to this Agreement for commercial sale, as it may be properly amended from time
to time by agreement of the Parties, and which is incorporated by this reference
as though fully set forth in this paragraph.
"Quality Agreement" means the Agreement set forth as Exhibit C to this Agreement
and incorporated by this reference as though fully set forth in this Agreement.
"Regulatory Authority" means the FDA or any equivalent or additional
governmental or regulatory agencies having jurisdiction with respect to INyX,
INyX's facilities, or the Products.
"Xxxxxxx" means Xxxxxxx Laboratories, Inc.
"Unique Materials" shall have the meaning set forth in Section 3.12 of this
Agreement.
ARTICLE 2
PRODUCT SPECIFICATIONS AND MANUFACTURE
--------------------------------------
2.1 Manufacture of Products
-----------------------
During the term of this Agreement, and subject to the terms and conditions of
this Agreement, INyX shall formulate, fill and package the Products in
accordance with their respective Product Specifications, according to the terms
of this Agreement and the Quality Agreement, as they may be amended from time to
time.
2.2 Conformance to Product Specifications
-------------------------------------
Products (and jointly approved for the purposes of this section, the Placebo)
shall conform to the Product Specifications, the terms of the Quality Agreement,
and all specifications provided in the Customer's IND or NDA. Notwithstanding
the foregoing, if the Customer accepts Product in accordance with the provisions
of this Agreement and the Quality Agreement, this Section 2.2 shall be deemed to
have been satisfied.
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2.3 Labeling
--------
INyX will label and package Product in finished form, pursuant to a firm
purchase order accepted by INyX as described in Section 3.4, provided, however,
that the Customer shall be responsible for the origination of artwork and text,
as well as final approval before manufacture, of the Labeling.
2.4 Raw Materials
-------------
INyX shall source all raw materials used in manufacture of the Products firstly
from sources designated by the Customer. The Customer shall purchase the raw
materials and deliver same to INyX. INyX and the Customer agree to jointly
develop a procedure for testing raw materials that meets all FDA requirements,
prior to the Customer's issuance of its first order for Products hereunder.
2.5 Batch Testing; Certificate of Authenticity
------------------------------------------
INyX shall test, or cause to be tested, in accordance with the Product
Specifications, each batch of Product manufactured pursuant to this Agreement
before delivery to the Customer. Prior to each shipment of Product, INyX shall
provide to the Customer a Certificate of Analysis attesting to the quality of
each batch contained within the shipment, including review and approval by the
appropriate quality control unit of all batch production and control records.
INyX shall maintain and provide the Customer with such documentation as may be
required for compliance with FDA and other applicable regulators.
2.6 Good Manufacturing Practice
---------------------------
INyX shall manufacture, store and prepare all Products for shipping in
accordance with the current Good Manufacturing Practices ("cGMPs") of the FDA,
and the equivalent manufacturing requirements of the European Regulatory
Authorities, in an FDA inspected and ISO9000 certified facility, currently
envisioned to be INyX's facility in Runcorn, U.K. INyX may not change
manufacturing of Products to an alternate facility without first obtaining the
Customer's written approval, including the approvals required pursuant to the
Quality Agreement, such approvals not to be unreasonably withheld.
2.7 DMF
---
To the extent required, INyX shall maintain a DMF, like filing or relevant
registration certificate, suitable for INyX's manufacture of Products, with the
applicable regulatory agencies (including FDA) and shall ensure that its "active
status" is maintained. INyX shall use Commercially Reasonable Efforts to timely
accomplish, and bear the costs of, preparing for regulatory inspection, approval
and associated filings required for the manufacture of Products. The Customer
shall directly pay or reimburse INyX for any fees and payments to such
regulatory agencies required for such inspection, approval and associated
filings (e.g., any FDA inspection fee); it is understood that the Customer is
not responsible for fees and payments related to the general operation of INyX's
business or facilities. INyX will provide letter(s) granting the Customer and
its designees the right of cross-reference to the DMF. INyX reserves the right
to cancel such letter(s) in case of termination of this Agreement; provided
that, any such letter(s) are first offered to be transferred to the Customer and
the Customer declines the transfer.
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2.8 Inspections
-----------
The Customer has the right at any time during the term of this Agreement, upon
reasonable prior notice and during reasonable business hours and without
disruption to INyX's business, to inspect INyX's facility, and to make FDA-type
inspections at its plant to satisfy itself that INyX manufactures and documents
the Product according to current cGMPs, consistent with FDA standards and
requirements. Such inspections may only be made by individuals reasonably
acceptable to INyX. The provisions of this Section 2.8 are subject to the
confidentiality provisions of Article 7. The Customer shall be responsible for
its costs of travel and accommodation for such inspections.
2.9 Changes to Product Specifications
---------------------------------
(a) If the Customer desires any material change to the Product
Specifications or manufacturing process, the Customer shall deliver,
one-hundred and twenty (120) days prior to the expected date of
implementation, written notice to INyX specifying such change
desired by the Customer, and INyX shall respond to any such notice
within thirty (30) days after INyX's receipt thereof; provided,
however, that the Product Specifications or process shall not be
supplemented, modified or amended in any respect without the prior
written agreement of the Parties. INyX will use Commercially
Reasonable Efforts to implement changes within one-hundred and
twenty (120) days. If the Customer requests a change to a Product
Specification, including the manufacturing process, and INyX agrees
that such change is feasible, such change shall be incorporated
within the Product Specification pursuant to a written amendment to
this Agreement. The Customer shall be responsible for obtaining any
required FDA approval prior to implementation of such a change at
the Customer's cost.
(b) INyX will communicate to the Customer in a timely manner any change
in the Product Specification, including the manufacturing process,
initiated by INyX, and will obtain the Customer's written approval
by way of written amendment of this Agreement incorporating such
change within the Product Specification prior to implementation of
the change. No such change may be instituted except in compliance
with this Agreement and the Quality Agreement. The Customer shall
have the option of obtaining, or having INyX obtain any required FDA
approval prior to implementation of such a change. INyX may provide
additional services in conjunction with the manufacture of Products,
such as additional formulation,
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process development or stability testing, at the request of the
Customer and pursuant to the Customer's purchase order, and all data
and results from such additional services shall be owned by the
Customer and protected as confidential under this Agreement.
2.10 Customer Representative at INyX
-------------------------------
The Customer may, at the Customer's expense, place a company representative
on-site at INyX's manufacturing facility during the term of this Agreement.
Subject to the following sentence, such representative shall have full access to
all operations, documents, and records that specifically pertain to the
manufacture of the Products. The Customer Representative shall accept INyX's
procedures regulating external customer relationships (including GMP training,
guarantee of confidentiality, and health procedures), and shall not materially
disrupt INyX's operations.
ARTICLE 3
PLANNING AND SUPPLY
-------------------
3.1 Production
----------
INyX will produce Products to meet the mutually agreed upon forecasts, subject
to the provisions of this Article 3. INyX will keep the Customer informed of all
scheduled production activity for the Products.
3.2 Termination of Obligation
-------------------------
INyX's obligation to supply Product to the Customer shall terminate pursuant to
the provisions of Article 10 below.
3.3 Forecasts
---------
The Customer shall provide INyX with an annual forecast for budgeting and
production planning purposes. The Customer shall also deliver to INyX a monthly
update, including a 90-day rolling forecast setting forth the Customer's
required quantities and delivery dates for each Product. Forecasts shall include
the amounts of each Product to be manufactured and supplied by INyX and the
expected timing for the delivery of each shipment during the forecast period.
The Parties shall discuss each of the forecasts and shall mutually agree in good
faith on the appropriateness of each forecast versus anticipated demand for
Product.
3.4 Purchase Orders
---------------
The Customer will place written purchase orders directly or through its
designated representatives with INyX approximately 10 weeks prior to requested
shipment date, including the following details: number of units, requested
shipping date, shipping instructions and the
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Customer's order reference number including the price calculated according to
this Agreement. Each purchase order issued pursuant to this Agreement shall be
governed by the terms and conditions of this Agreement, and shall override any
conflicting provisions in any invoice or packing slip generated by INyX with
respect to the details set forth in this Section 3.4.
3.5 Receipt and Acceptance by INyX
------------------------------
INyX shall promptly acknowledge its receipt of purchase orders and inform the
Customer of the anticipated dates of manufacture and delivery of each Product
presentation to the Customer. INyX shall respond in writing as to its acceptance
of each firm purchase order within fifteen (15) days of receipt of such order.
Any portion of the order that exceeds the most recent corresponding twelve (12)
month forecast (supplied pursuant to Section 3.3) by more than one hundred ten
percent (110%) will be accepted at INyX's discretion. Once a specified quantity,
form and delivery date terms have been agreed to by the Parties in any purchase
order placed pursuant to this Section 3.5, the purchase order may not be
canceled by either Party except as provided in Section 3.10 or in Section 3.11
below.
3.6 Shipment; Delays
----------------
INyX shall use Commercially Reasonable Efforts to ship Product to the Customer
by the delivery date specified in the accepted purchase order. If INyX believes
there will be a significant delay in shipment of Finished Product beyond the
delivery dates specified in any accepted purchase order, INyX shall promptly
inform the Customer of such expected delay and shall use Commercially Reasonable
Efforts to minimize the delay.
3.7 Change Orders
-------------
The time of delivery and quantities specified in a purchase order accepted by
INyX pursuant to Section 3.5 above shall be binding upon the Parties and may not
be changed or canceled, except as provided in Sections 3.9 and 3.10 below.
3.8 Increased Demand
----------------
INyX will use Commercially Reasonable Efforts to accommodate the Customer's
requests for units in excess of those reserved for the Customer and set forth in
Exhibit B to this Agreement; provided, however, that it shall not be a breach of
this Agreement if INyX, despite its Commercially Reasonable Efforts, is unable
to supply quantities of Product to the Customer in excess of 110% of the annual
forecast supplied pursuant to Section 3.3 for that year.
3.9 Postponement of Manufacturing; Penalties
----------------------------------------
(a) By the Customer. The Customer may postpone a purchase order for
production in accordance with the provisions in this Section. The
Customer may postpone each purchase order one time. In the event of
postponement pursuant to this Section
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3.9, INyX shall use Commercially Reasonable Efforts to reschedule
the postponed order to a date agreeable to both Parties. Regardless
of the amount of notice, if the Customer does not reschedule the
Date of Manufacture to a date within forty-five (45) calendar days
of the originally scheduled date, the purchase order shall be deemed
cancelled, and shall accrue the penalties, if any, pursuant to
Section 3.10.
(b) By INyX.
(i) INyX shall use Commercially Reasonable Efforts to meet the
terms of a purchase order that it accepts, taking into account
mutually agreed upon forecasts under Section 3.3, available
plant capacity and timing of its production.
(ii) If INyX fails to meet the deadlines specified in a purchase
order that it has accepted, or specified in its acceptance of
the purchase order, and the failure is caused by the gross
negligence or willful misconduct of INyX, then the Customer
may require INyX to supply the undelivered Product at the
earliest possible future date (subject to a penalty of 15% of
the cost of such undelivered Product for each month's delay)
unless otherwise agreed by the Customer, or the Customer may
at its option cancel such portion of the order without
penalty.
3.10 Cancellation of Purchase Orders; Penalties
------------------------------------------
The Customer may cancel a purchase order for production in accordance with the
provisions in this Section. The charge for cancellation shall be determined
according to the following schedule:
(a) If the Customer gives at least ninety (90) calendar days notice
prior to the manufacturing date assigned by INyX pursuant to Section
3.5, there shall be no penalty for cancellation.
(b) If the Customer gives less than sixty (60) calendar days and more
than twenty-one (21) days notice, INyX may invoice the Customer for,
and the Customer shall be
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required to pay to INyX an amount equal to thirty percent (30%) of
the amount owed under the purchase order, calculated in accordance
with Exhibit B; provided, however, that INyX must use Commercially
Reasonable Efforts to reallocate the suite to manufacture another
product of similar value to INyX on the originally scheduled date,
and no charge shall be assessed to the Customer if such efforts are
successful.
(c) If the Customer gives twenty one (21) days or less notice but more
than fourteen (14) days notice INyX may invoice the Customer for,
and the Customer shall be required to pay to INyX an amount equal to
fifty percent (50%) of the amount owed under the purchase order,
calculated in accordance with Exhibit B; provided, however, that
INyX must use Commercially Reasonable Efforts to reallocate the
suite to manufacture another product of similar value to INyX on the
originally scheduled date, and no charge shall be assessed to the
Customer if such efforts are successful.
(d) If the Customer gives less than fourteen (14) days notice of
cancellation, INyX may invoice the Customer for, and the Customer
shall be required to pay, an amount equal to one hundred (100%)
percent of the amount owed under the purchase order, calculated in
accordance with Exhibit B.
3.11 Shipment; Inspection; Rejection
-------------------------------
(a) Shipment of Product. INyX shall ship, or cause to be shipped at the
Customer's expense, the Product to the Customer or such
destination(s) as the Customer may designate in writing. Delivery of
Product to a common carrier authorized by the Customer shall
constitute delivery to the Customer, and risk of loss shall pass to
the Customer at that time. INyX agrees to provide support to assist
the Customer to pursue any Product related claims it may have
against carriers, provided that the Customer shall reimburse INyX
for any out-of-pocket expenses INyX may incur in providing such
support. All invoices and other shipping documents shall be sent by
first class mail or by fax to the Customer's address for notices
under this Agreement, directed to the attention of Purchasing
Department, Xxxxxxx Laboratories, Inc., 0000 Xxxxx 000, Xxx Xxxx, XX
00000.
(b) Non-Conforming Product. The Customer may reject any batch of Product
that does not conform to the Manufacturing Standards, or that has
less than eighteen (18) months remaining before its expiration date,
subject to the terms of this Section and the Quality Agreement.
Within thirty (30) days after INyX's internal release of Product,
the Customer shall inspect the Product and notify INyX whether it
will accept or reject the Product. No inspection under this Section
shall relieve INyX of its obligations and warranties under this
Agreement. If the Customer rejects all or any part of any shipment
of Product, the procedures to be followed are:
(i) the Customer shall submit to INyX in writing any claim that
the Product does not conform with the Product Specifications
or cGMPs, accompanied by a report of the Customer's analysis
(which analysis shall be conducted in good faith) and a sample
of the Product at issue, explaining in reasonable detail the
basis on which the allegedly nonconforming Product does not
meet the Product Specifications. Once nonconformance is
confirmed and fault is determined to belong with INyX, the
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Customer shall not be obligated to pay for such nonconforming
shipment of Product. Only those tests listed in the Product
Specifications may be used to demonstrate nonconformance of
Product.
(ii) INyX shall conduct its own analysis of the sample in good
faith within thirty (30) days after the receipt by INyX of the
report and sample from the Customer, and provide the results
to the Customer.
(A) If after INyX's own analysis of the sample INyX agrees
with the claim of nonconformity, the Customer shall
promptly inform INyX if the Customer wishes to have INyX
replace the nonconforming Product with conforming
Product. If the Customer wishes to receive such
replacement Product, INyX shall provide such replacement
as soon as reasonably practicable thereafter, in which
case the Customer shall be obligated to pay only for
such replacement Product. The Customer shall not be
obligated to pay for the nonconforming Product, and INyX
shall: (1) credit the Customer for the amount paid by
the Customer to INyX for the nonconforming Product if
the Customer has already paid for such nonconforming
Product or (2) cancel its invoice to the Customer for
such nonconforming Product if the Customer has not yet
paid for such nonconforming Product, and the Customer
shall not be obligated to pay such cancelled invoiced
amount.
(B) If, after its own analysis, INyX does not agree with the
claim of nonconformity or determines that the Customer
is responsible for the nonconformity, such Product shall
be tested for conformance with the applicable Product
Specifications by an independent third party testing
laboratory mutually acceptable to both Parties. The
independent analysis shall be binding on both Parties
solely for the purpose of determining whether such
Product may be rightfully rejected.
(iii) After a final determination that the Product shipment is:
(A) nonconforming, and if INyX is responsible for the
nonconformity, the Customer shall return or destroy it
at INyX's request and cost in the most cost effective
and environmentally safe and appropriate manner
available, consistent with federal, state and local laws
and regulations;
(B) conforming, the Customer shall forthwith pay INyX for
such Product in accordance with the terms of this
Agreement.
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(iv) If conforming Product supplied under this Agreement becomes
nonconforming or unsuitable at no fault of INyX, the Customer
will remain obligated to pay INyX for such Product. At INyX's
request, the Customer shall return such unsuitable Product to
INyX. Otherwise, the Customer shall destroy it in the most
environmentally safe and appropriate manner available,
consistent with federal, state and local laws and regulations.
(c) Notwithstanding the other provisions of this Section 3.11, the
Customer shall have no right to reject any Product that fails to
conform with the Manufacturing Standards if the nonconformance is
attributable to (i) events outside of INyX's control that occurred
after delivery to a common carrier, or (ii) processes, procedures or
Product components specified by the Customer in the Product
Specifications, provided that INyX followed or used such processes,
procedures and Product components materially in accordance with the
Product Specifications.
3.12 Unique Materials
----------------
The Customer shall reimburse INyX for its actual costs expended for the purchase
of "Unique Materials" (i.e., certain raw materials, artwork, printed cans,
labels, cartons and special valves) purchased by INyX expressly to meet its
performance obligations under this Agreement in reliance upon a firm purchase
order pursuant to Section 3.4 and which later are made obsolete, or to the
extent that such Unique Materials remain on hand at the expiration of this
Agreement as provided under Section 10.1. For purposes of this Section, material
is obsolete if it cannot be incorporated into the Product due to changes
mandated by a Regulatory Authority, changes directed by the Customer, or the
Customer-mandated cancellation or postponement. Once material becomes obsolete,
INyX may invoice the Customer for the acquisition costs of such obsolete
material from time to time, which invoices shall identify the material in
question and shall be accompanied by a reasonably detailed statement of the
cause of such obsolescence and a certification that INyX has disposed of such
materials in accordance with the terms of this Agreement.
3.13 Risk of Losz
------------
Risk of loss of Product shall be with INyX until delivery of Product to a common
carrier pursuant to Section 3.11 of this Agreement. Notwithstanding the
forgoing, INyX shall not be liable for loss of Product caused by an event of
force majeure or the Customer's negligence or willful misconduct.
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3.14 Insurance
---------
INyX shall at its own expense obtain and maintain workers' compensation and
comprehensive general liability insurance with respect to performance under this
Agreement, in the amount of Five Million British Pounds Sterling
((pound)5,000,000).
ARTICLE 4
PRICE AND PAYMENT TERMS
-----------------------
4.1 Price for Products
------------------
The Customer shall pay INyX for Products in amounts to be agreed for each
Product and for each size or formulation. The agreed upon price for each Product
shall be set forth in the document attached as Exhibit B to this Agreement,
which Exhibit may be amended from time to time by the mutual written agreement
of the Parties.
4.2 Invoices
--------
INyX shall submit to the Customer an invoice five (5) days after INyX's internal
release of Product. The Customer shall make payment of each invoice within
forty-five (45) days after receipt by the Customer. If within forty-five (45)
days after the delivery of Product and the accompanying Certificate of Analysis
to the Customer, the Customer demonstrates non-conformance under Section 3.11
and INyX agrees with such finding, the Customer shall not be obligated to pay
for such non-conforming shipment.
4.3 Exclusivity
-----------
The Parties agree to deal with each other exclusively with respect to the
manufacture and supply of topical and foam aerosol products used for
dermatological applications (together with * * * , the "Dermatological
Products") during the term of this Agreement (the "Exclusivity Period"),
including extensions and renewals thereof. This exclusivity arrangement:
(a) shall not apply to the manufacture and supply of Dermatological
Products in respect of the current customers of INyX (formerly the
customers of Miza Pharmaceuticals, Inc. and its subsidiaries) such
Dermatological Products and customers to be set out in Exhibit
4.3(a). INyX shall be free to continue to supply such Dermatological
Products to such customers; and
(b) may, at the request of INyX, be suspended for the manufacture of
certain Dermatological Products upon obtaining the consent of the
Customer, such consent not to be unreasonably withheld.
4.4 * * *
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4.4 Currency
--------
Amounts due to INyX under this Agreement are payable in U.S. Dollars, based on
the average exchange rate published in the Wall Street Journal from ten (10)
days prior through the date of the Customer's first rolling forecast provided to
INyX pursuant to Section 3.3 above. If the exchange rate published in the Wall
Street Journal from ten (10) days prior through the date of a subsequent six (6)
month rolling forecast differs by more than five percent (5%) from the exchange
rate then prevailing between the Parties, the Party against which such
difference works may, within ten (10) days, request a renegotiation of such
exchange rate with the other Party. The difference in any such renegotiated
exchange rate not to exceed fifty percent (50%) of the difference between said
then-prevailing and published exchange rates.
4.5 Set-Off
-------
The parties acknowledge that, INyX has made a convertible promissory note of
even date in favour of the Customer in the face amount of (pound)2,500,000.00
British Pounds Sterling (the "Promissory Note"). INyX agrees that the Customer
may, from time to time, at its sole discretion, set-off against amounts due
hereunder any overdue interest or principal payments accruing due pursuant to
the Promissory Note, upon providing INyX ten (10) business days notice of the
Customer's intention to set-off such amounts; and to permit INyX to cure any
default under the Promissory Note as provided therein.
ARTICLE 5
WARRANTIES
----------
5.1 Quality
-------
Each shipment of Product under this Agreement shall have been manufactured in
accordance with U.S. Current Good Manufacturing Practices in a duly licensed
facility and shall have been subject to a quality control inspection by the
Customer in accordance with the Product Specifications and with the Customer's
then current quality control standards and systems. INyX shall number each
Product shipment with a vendor lot number that is traceable to raw materials
and/or components used to manufacture such Product.
5.2 Representations and Warranties
------------------------------
(a) INyX warrants that Product delivered to the Customer pursuant to
this Agreement shall, at the time of delivery:
(i) have been manufactured, filled, packaged, stored and shipped
in accordance with all applicable laws, rules, regulations or
requirements;
(ii) have been manufactured, filled, packaged and stored in
accordance with, and will conform to, the Product
Specifications;
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(iii) will be free from defects in material, manufacturing and
workmanship for the shelf life of the Product as set forth in
the Product Specifications;
(iv) not be adulterated or misbranded within the meaning of the
Federal Food, Drug and Cosmetic Act (the "Act") as amended, or
within the meaning of any applicable state or municipal law in
which the definitions of adulteration and misbranding are
substantially the same as those contained in the Act, as the
Act and such laws are constituted and effective at the time of
delivery; and
(v) will not be an article which may not, under the provisions of
Sections 404 and 505 of the Act, be introduced into interstate
commerce.
(b) Licensing. INyX represents and warrants that it has obtained and
will maintain on a current basis and will comply with all licenses,
permits and approvals of applicable governmental agencies as may be
required to manufacture, test and store the Product pursuant to this
Agreement and perform its other obligations under this Agreement.
INyX shall be responsible for obtaining and maintaining licenses and
permits for manufacture, testing and storage of the Product and
ensuring that its facilities used in the manufacture of the Product
meet cGMPs in all respects.
(c) Compliance with Laws. INyX represents and warrants that it shall
comply with all federal, state, local and foreign laws, regulations
and other requirements applicable to the manufacture, testing and
storage of the Product and the performance of INyX's obligations
under this Agreement. INyX shall have sole responsibility for
adopting and enforcing safety procedures for the handling and
manufacture of the Product at its facilities and the proper handling
and proper disposal of waste relating to the Product.
5.3 Limitations; Indemnification
----------------------------
(a) Limitations on Warranty. The warranty furnished in this Article 5
shall not apply to defects caused by accident or willful damage,
abuse, misuse, neglect, improper testing, handling, storage or use
after delivery by INyX of the Product in question to the Customer.
(b) No Implied Representations; Warranties or Conditions. EXCEPT AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER INYX NOR THE
CUSTOMER MAKES ANY REPRESENTATIONS OR WARRANTIES AND THERE ARE NO
CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT
TO PRODUCT SUPPLIED UNDER THIS AGREEMENT, INCLUDING, WITHOUT
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LIMITATION, ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS WITH
RESPECT TO NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OF SUCH PRODUCT, OR ARISING FROM A COURSE OF
DEALING OR USAGE OF TRADE PRACTICE.
(c) Limitation of Liability. EXCEPT FOR ANY LOSS, LIABILITY, DAMAGE OR
OBLIGATION ARISING OUT OF OR RELATING TO THE DISCLOSURE OF
CONFIDENTIAL INFORMATION PURSUANT TO ARTICLE 7 OR AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO EVENT SHALL EITHER
PARTY HAVE ANY LIABILITY TO THE OTHER PARTY OR ANY OTHER THIRD PARTY
FOR ANY LOST OPPORTUNITY, COSTS OF PROCUREMENT OF SUBSTITUTE GOODS
OR SERVICES, OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL,
PUNITIVE OR SPECIAL DAMAGES ARISING OUT OF THIS AGREEMENT, UNDER ANY
CAUSE OF ACTION OR THEORY OF LIABILITY (INCLUDING NEGLIGENCE), AND
WHETHER OR NOT SUCH PARTY TO THIS AGREEMENT HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE. THESE LIMITATIONS SHALL APPLY
NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED
REMEDY. INYX'S MAXIMUM LIABILITY UNDER THIS AGREEMENT SHALL BE
LIMITED TO THE INYX'S ACTUAL RECOVERY UNDER ITS COMPREHENSIVE
GENERAL LIABILITY INSURANCE WHICH AS OF THE DATE HEREOF CARRIES A
COVERAGE OF FIVE MILLION BRITISH POUNDS STERLING.
(d) INyX shall use commercial efforts in pursuing claims under its
comprehensive general liability insurance in order to reasonably
permit the Customer to recover losses, as its interest may appear,
pursuant to this Agreement. Upon the Customer's request, INyX shall
assign to the Customer (to the extent it can legally do so) its
rights to insurance proceeds, provided the Customer has a valid
claim against INyX under this Agreement that is either
unconditionally admitted by INyX or is otherwise finally confirmed
by court action or other dispute resolution process.
ARTICLE 6
TECHNOLOGY TRANSFER
-------------------
6.1 Second Source
-------------
INyX shall assist the Customer (at the Customer's cost and expense) in
qualifying a second source for Product, providing technical assistance and
documentation as necessary, including
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such manufacturing technology and know-how so as to permit another entity to
manufacture Product, and INyX agrees to cooperate with the Customer to
facilitate the technology transfer.
6.2 Reimbursement
-------------
The Customer agrees to reimburse INyX for INyX's expenses in providing the
assistance required in Section 6.1 for any second source other than an Affiliate
of INyX.
6.3 Intellectual Property
---------------------
INyX shall use Commercially Reasonable Efforts to assist the Customer with the
preparation and filing of patent applications in connection with the Products;
provided that, the Customer shall reimburse INyX for all out-of-pocket costs and
expenses incurred by INyX.
For greater clarity, INyX acknowledges that all intellectual property created
specifically in connection with the Products (the "Intellectual Property"),
including formulations, inventions or discoveries (first made or reduced to
practice in the performance of INyX's obligations hereunder) shall be the
property of the Customer. INyX shall, when requested by the Customer, execute
all such assignments, consents and other documents reasonably necessary to
assign to the Customer all right, title and interest in and to all the
Intellectual Property, and shall use best efforts to cause its employees, agents
and subcontractors to execute the necessary documents to give effect to this
provision.
The Customer hereby grants INyX a royalty-free, non-exclusive, worldwide right
and license to make, use and sell products incorporating Intellectual Property,
subject always to INyX's obligations hereunder.
ARTICLE 7
CONFIDENTIALITY
---------------
7.1 Confidentiality
---------------
(a) Confidential Information. The Parties acknowledge that by reason of
their relationship to each other under this Agreement, each will
have access to certain information and materials concerning the
other's business, plans, trade secrets, customers (including, but
not limited to, customer lists), technology, and/or products that is
confidential and of substantial value to that Party, which value
would be impaired if such information were disclosed to Third
Parties ("Confidential Information"). Each Party agrees that it will
not use in any way other than expressly authorized or contemplated
under this Agreement, nor disclose to any third party, any such
Confidential Information revealed to it by the other Party (except
that Confidential Information may be disclosed, as required for the
purposes of this Agreement, to any Regulatory Authority, an
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Affiliate, assignee, distributor, consultant or third party
contractor or research and development organization under similar
written obligations of non-disclosure and non-use), and will take
every reasonable precaution to protect the confidentiality of such
information and with no less restrictive precautions than it takes
to protect its own confidential information. If Confidential
Information is required to be disclosed in response to a valid order
by a court, Regulatory Authority or other government body of
competent jurisdiction, or if otherwise required to be disclosed by
law, or if necessary to establish the rights of either Party under
this Agreement, the receiving Party shall use reasonable efforts to
provide the disclosing Party with advance notice of such required
disclosure to give the disclosing Party sufficient time to seek a
protective order or other protective measures, if any are available,
for such Confidential Information.
(b) Exceptions. For purposes of this Agreement, information shall be
deemed Confidential Information if such information, by its nature
or due to the context within which it is disclosed, is obviously
intended by the disclosing Party to be kept confidential even if not
identified as such in writing or with legends or other markings. The
person disclosing Confidential Information shall endeavor to confirm
verbally disclosed Information as "CONFIDENTIAL" in writing, given
the understanding that failure to do so does not constitute a
designation of non-confidentiality, particularly when the
confidential nature is apparent from context and subject matter.
Upon request by a Party, the other Party will advise whether or not
it considers any particular information or materials to be
Confidential Information. Confidential Information does not include
information, technical data or know-how that:
(i) is or becomes publicly available through no fault of the
receiving Party or its individual employees, agents or members
amounting to a breach of this Agreement;
(ii) is lawfully obtained on a non-confidential basis by the
receiving Party from a third party who is not obligated to
retain such information in confidence;
(iii) the receiving Party can demonstrate, by competent evidence,
was known to it or any of its Affiliates from a source other
than the disclosing Party or any of its Affiliates prior to
the disclosure under this Agreement;
(iv) the receiving Party can demonstrate by its written records is
independently developed by employees of the receiving Party or
an Affiliate of the receiving Party, which employees were
neither privy to nor had access to the Confidential
Information and which is developed without use in any way of
the Confidential Information;
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(v) must be disclosed to governmental agencies, provided that: (A)
this exception shall only apply to disclosure to such
agencies, and not to any other person or entity; and (B) the
disclosing Party shall (1) provide the other Party with prompt
notice (including copies of all written requests or demands)
of any proposed disclosure to any governmental agency, with an
explanation of the Confidential Information of the other Party
to be disclosed; and (2) cooperate in any lawful effort by the
other Party to prevent, limit or restrict disclosure of its
Confidential Information to such government agency.
7.2 Remedy
------
If either Party breaches any of its obligations with respect to this Article 7,
or if such a breach is likely to occur, the other Party shall be entitled to
seek equitable relief, including specific performance or an injunction, in
addition to any other rights or remedies, including money damages, provided by
law, without posting a bond.
7.3 Agreement Terms
---------------
Subject to Section 15.2 and the exclusions set forth in Section 7.1(b), the
Parties shall treat the terms and conditions of this Agreement as Confidential
Information; provided, however, after written notification to the other Party,
each Party may disclose the existence of this Agreement and the material terms
and conditions of this Agreement under circumstances that reasonably ensure the
confidentiality thereof to: (a) any government or regulatory authorities,
including without limitation the United States Security and Exchange Commission
pursuant to applicable law (excluding, to the extent legally permitted,
disclosure of financial terms in any publicly available versions of information
so disclosed), (b) its legal representatives, advisors and prospective
investors, and (c) to the Customer's licensors to the extent required for
compliance with the Customer's obligations under third party licenses.
7.4 Return of Confidential Information
----------------------------------
Within ten (10) days following the termination of any agreement between the
Parties with respect to the subject matter the receiving Party agrees to
promptly return all tangible items relating to the Confidential Information,
including all written material, photographs, models, compounds, compositions and
the like made available or supplied by the disclosing Party to the receiving
Party, and all copies thereof, upon the request of the disclosing Party, except
such records as may be required to be kept for FDA or other government
regulatory compliance. Recipient further agrees to identify those persons to
whom the Confidential Information that is the subject of this Agreement was
disclosed upon request of the disclosing Party.
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7.5 Inside Information
------------------
INyX understands that Confidential Information may constitute "inside
information" of the Customer for securities purposes and agrees to refrain from
any unlawful disclosure, trading or other improper use of such information.
7.6 Connetics Information
---------------------
Miza Pharmaceuticals, Inc. has, to the best of INyX's knowledge (after due
enquiry), returned to Connetics Corporation all Confidential Information of
Connetics Corporation under the provisions of the Amended and Restated
Manufacturing and Supply Agreement between Miza Pharmaceuticals, Inc. and
Connetics Corporation dated September 19th, 2001.
ARTICLE 8
ASSIGNMENT
----------
8.1 Assignment by INyX
------------------
INyX shall have no right or authority to assign the Agreement or any portion of
the Agreement, to sublet or subcontract in whole or in part, or otherwise
delegate its performance under this Agreement, without the Customer's prior
written consent, such consent not to be unreasonably withheld. Notwithstanding
the foregoing, nothing in this Agreement shall prohibit INyX from assigning this
Agreement to any Affiliate of INyX that may from time to time own or operate the
facility at Runcorn, England. No such assignment shall relieve INyX of primary
liability for the performance of its obligations under this Agreement.
8.2 Assignment by the Customer
--------------------------
The Customer may assign this Agreement. INyX agrees that if this Agreement is
assigned to any third party or Affiliate, all the terms and conditions of this
Agreement shall obtain between such third party or Affiliate and INyX with the
same force and effect as if said Agreement had been made with such third party
or Affiliate in the first instance, provided that no such assignment shall
relieve the Customer of primary liability for the due performance of this
Agreement.
ARTICLE 9
FORCE MAJEURE
-------------
9.1 Force majeure
-------------
Neither Party shall be considered in default of performance of its obligations
under this Agreement, except any obligation under this Agreement to make
payments when due, to the extent that performance of such obligations is delayed
by contingencies or causes beyond the reasonable control and not caused by the
negligence or willful misconduct of such Party, including but not limited to
strike, fire, flood, earthquake, windstorm, governmental acts
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or orders or restrictions, or force majeure, to the extent that the failure to
perform is beyond the reasonable control of the nonperforming Party, if the
Party affected shall give prompt written notice of any such cause to the other
Party. The Party giving such notice shall thereupon be excused from such of its
obligations under this Agreement for the period of time that it is so disabled.
ARTICLE 10
TERM AND TERMINATION
--------------------
10.1 Term
----
This Agreement shall expire on March 6, 2007 (the "Initial Term"), after which
this Agreement may be renewed for successive periods of one calendar year each,
any such agreement to renew to be confirmed in writing by the Parties. At the
end of the Initial Term, this Agreement shall, at the Customer's option,
automatically renew for successive one-year periods under the same terms and
conditions set forth under this Agreement (or such other terms agreed in writing
by the Parties) until terminated in writing in accordance with the provisions of
this Agreement.
10.2 Termination for Material Breach
-------------------------------
Either Party may terminate this Agreement upon written notice if the other Party
has breached any of its material obligations under this Agreement, and (a) such
breach has not been cured within 60 days after written notice of the breach, or
(b) if a plan, reasonably acceptable to the non-breaching Party, is not
implemented to cure as soon as practicable after notice of the breach
10.3 Termination upon Insolvency
---------------------------
Either Party may, in addition to any other remedies available to it by law or in
equity, terminate this Agreement immediately by written notice to the other
Party upon (i) the filing by the other Party of a voluntary petition in
bankruptcy or seeking reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts or any other relief under
any bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, (ii) the filing against such other
Party of an involuntary petition in bankruptcy which is not dismissed within 60
days, (iii) the appointment of a receiver or trustee of any of such other
Party's property if such appointment is not vacated within 60 days, (iv) the
adjudication of such other Party as insolvent, or (v) the assignment of such
other Party's property for the benefit of its creditors.
10.4 Termination for Force Majeure
-----------------------------
Either Party may terminate this Agreement upon thirty (30) days written prior
notice in the event of the other Party's inability to substantially perform its
obligations under this Agreement for more than one hundred eighty (180) days due
to an event of force majeure as described in Article 9.
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10.5 Termination without Cause
-------------------------
Either Party may terminate this Agreement upon twelve (12) months' written
notice to the other Party.
10.6 Accrued Liabilities
-------------------
The termination of this Agreement for any reason shall not discharge either
Party's liability for obligations incurred under this Agreement and amounts
unpaid at the time of such termination. The Customer shall be liable to pay INyX
for any Product, work in progress and materials purchased by INyX to fulfill its
obligations under this Agreement, provided however that INyX shall make all
Commercially Reasonable Efforts to mitigate its damages under such
circumstances.
10.7 Return and Disposition of Property
----------------------------------
Upon the termination of this Agreement for any reason, each Party shall return
to the other Party or its designee all of such other Party's property,
including, but not limited to, all proprietary information, in its possession.
To the extent required by law or to comply with such Party's continuing
obligations under this Agreement, each Party may keep a single copy of tangible
property belonging to the other Party. INyX shall dispose of all bulk active
ingredients, raw materials, containers, and Labeling not necessary to complete
work in progress at the Customer's expense in accordance with the Customer's
reasonable instructions.
ARTICLE 11
INDEMNIFICATION
---------------
11.1 Indemnification by INyX
-----------------------
INyX shall, subject to Section 5.3, indemnify the Customer, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all suits, losses, actions,
demands, investigations, claims, damages, liabilities, costs and expenses
(including, without limitation, reasonable attorneys' fees and expenses)
(collectively, "Losses") brought by third parties arising from or occurring as a
result of:
(a) a nonconformity of Product with the warranties under Sections 5.1
and 5.2 except for any damages attributable to the negligence of the
Customer, its employees or agents;
(b) INyX's failure to comply with the Product Specifications;
(c) any willful act or omission or negligence of INyX or its employees,
agents or other contractors in the manufacturing and testing of the
Product; or
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(d) INyX's failure to comply with the Act and the regulations under the
Act in the production of Product.
(e) any breach (or alleged breach) by INyX of its representations,
warranties, or obligations under this Agreement;
(f) the manufacture or the storage of the Product prior to the date of
shipment of Product to the Customer by INyX or its Affiliates,
all except to the extent caused by the negligence or willful misconduct of
the Customer or its officers, agents, employees, Affiliates, sublicensees
or customers.
11.2 Indemnification by the Customer
-------------------------------
The Customer shall, subject to Section 5.3, indemnify INyX, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all Losses brought by third
parties arising from or occurring as a result of:
(a) failure by the Customer to comply with the Food Drug and Cosmetic
Act and the regulations under the Act;
(b) the handling or other use of the Product;
(c) any willful act or omission or negligence of the Customer or its
employees, agents or other contractors
(d) any breach (or alleged breach) by the Customer of its
representations, warranties, or obligations under this Agreement;
(e) the manufacture by the Customer or third parties contracted by the
Customer, or the storage of Product after the date of shipment of
Product to the Customer by INyX or its Affiliates,
all except to the extent caused by the negligence or willful misconduct of INyX
or its officers, agents, employees, Affiliates, sublicensees or customers.
11.3 Process
-------
If either Party expects to seek indemnification from the other pursuant to the
provisions of this Article 11, it shall promptly give notice to the indemnifying
Party of any such Claim. The indemnifying Party shall have the right to control
the defense of such Claim and the indemnified Party shall cooperate with the
indemnifying Party in the defense of such Claim. No settlement or compromise of
any Claim shall be binding on a Party hereto without its prior written consent.
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11.4 Patent Indemnification
----------------------
The Customer shall indemnify and hold INyX and its employees, servants and
agents harmless from and against any and all claims, demands, actions, suits,
losses, damages, costs, expenses (including reasonable attorney's fees), and
liabilities which INyX may incur, suffer or be required to pay by reason of any
patent infringement suit brought against INyX because of INyX's manufacture of
Product to the extent that the alleged infringement arose out of or related to
INyX's use of processes, compounds or other products the rights to which are
claimed to be owned by the Customer.
ARTICLE 12
AUDIT RIGHTS; INSPECTIONS
-------------------------
12.1 Inspections
-----------
The Customer, upon its own discretion and at its own cost and expense, is
entitled during ordinary business hours and at dates acceptable to INyX to
inspect or to have inspected, INyX's plant and procedures used for manufacture
and storage of the Products.
12.2 Books and Records
-----------------
INyX agrees to maintain and cause its Affiliates to maintain complete and
accurate books and records of account so as to enable the Customer to verify
amounts due and payable under this Agreement. In particular, INyX shall preserve
and maintain all such records and accounts required for audit for a period of
four (4) years after the calendar quarter for which the record applies.
12.3 Audit of INyX's Records
-----------------------
During the term of this Agreement, the Customer shall have the right upon two
(2) weeks notice to INyX to have an independent certified public accountant,
selected by the Customer and reasonably acceptable to INyX, audit INyX's records
during normal business hours; provided, however, that such audit shall not take
place more frequently than once a year and shall not cover records for more than
the preceding four (4) years.
12.4 Government Inspection
---------------------
INyX agrees to advise the Customer by telephone and facsimile immediately of any
proposed or announced visit or inspection, and as soon as possible but in any
case within twenty-four (24) hours of any unannounced visit or inspection, by
any Regulatory Authority of any facilities used by INyX in the performance of
its obligations under this Agreement. INyX shall provide the Customer with a
reasonable description of each such visit or inspection promptly (but in no
event later than five 5 calendar days) thereafter, and with copies of any
letters, reports or other documents (including Form 483's) issued by any such
authorities that relate to the Products, or
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such facilities, processes or procedures. The Customer may review INyX's
responses to any such reports and communications, and if practicable, and,
insofar as timely received, the Customer's reasonable views and requests shall
be taken into account prior to submission of such reports and communications to
the relevant Regulatory Authority.
ARTICLE 13
DISPUTES
--------
13.1 Arbitration
-----------
If the Parties' are unable to settle amicably any claim, dispute, controversy or
difference arising out of or in relation to or in connection with this Agreement
or for breach of this Agreement through consultation and negotiation in good
faith and a spirit of mutual cooperation, then the dispute shall be resolved
through binding arbitration in accordance with the rules of the American
Arbitration Association then in effect. Judgment upon the award rendered by the
arbitrators may be entered in any court having jurisdiction thereof. In any
arbitration pursuant to this section, the award shall be rendered by a majority
of the members of a board of arbitration consisting of three members, one being
appointed by each Party and the third being appointed by mutual agreement of the
two arbitrators appointed by the Parties. The place of arbitration shall be New
York, New York.
13.2 UN Convention Not Applicable
----------------------------
The Parties expressly disclaim application to this Agreement of the United
Nations Convention on Contracts for the International Sale of Goods, and agree
that it shall not govern or apply to this Agreement or its performance or
construction.
13.3 Governing Law
-------------
This Agreement shall be governed, controlled, interpreted and defined by and
under the laws of the State of New York and the United States without regard to
that body of law known as conflicts of law; provided that issues relating to the
validity and enforceability of patents shall be governed by the laws of the
jurisdiction by which such patent was granted.
ARTICLE 14
NOTICES
14.1 Notice.
-------
Any notice required or permitted by this Agreement shall be in writing and shall
be sent by prepaid registered or certified mail, return receipt requested; by
facsimile; by internationally recognized courier; or by personal delivery, in
each case addressed to the other Party at the address below or at such other
address for which such Party gives notice under this Agreement.
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If to the Customer at:
Xxxxxxx Laboratories, Inc.
Attention: President and Chief Executive Officer
000 Xxxxxxxx Xxxxxx
Xxxxx Xxxxxx, Xxxxxxx, XXX 00000
If to INyX, at:
INyX Pharma Ltd.
Attention: Xxxxx Xxxxxxx
0 Xxxxxxx Xxxxx, Xxxxx Xxxx
Runcorn, Cheshire, UK WA7 1S&
Such notice shall be deemed to have been given when delivered or, if delivery is
not accomplished by some fault of the addressee, when tendered. Either Party may
change its address for notice by delivering a written notice of the new address
in accordance with this Article.
ARTICLE 15
NATURE OF RELATIONSHIP
----------------------
15.1 No Agency; Independent Contractor
---------------------------------
Each Party is and shall be considered to be an independent contractor of the
other Party. Neither Party shall be the legal agent of the other for any purpose
whatsoever and neither Party has any right or authority to make or underwrite
any promise, warranty or representation, to execute any contract or otherwise to
assume any obligation or responsibility in the name of or on behalf of the other
Party. Neither Party shall be bound by or liable to any third persons for any
act or for any obligation or debt incurred by the other toward such third party,
except to the extent specifically agreed to in writing by the Party so to be
bound.
15.2 Public Statements
-----------------
The Parties shall endeavor to provide courtesy copies of any public
announcements concerning the relationship created by this Agreement. Neither
Party shall make any representations concerning the other without the prior
consent from the other Party. Notwithstanding the foregoing, each Party consents
to references to it in reports or documents or other disclosures sent to
stockholders or filed with or submitted to any governmental authority or stock
exchange. Except for such disclosure as is required by applicable law and/or
stock exchange regulation, neither Party shall make any announcement, news
release, public statement, publication or presentation relating to the existence
of this Agreement or the arrangements referred to in this Agreement without
first notifying the other Party.
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ARTICLE 16
ADDITIONAL PROVISIONS
---------------------
16.1 Headings
--------
Article and section headings contained in this Agreement are included for
convenience of reference only and shall not affect in any way the meaning or
interpretation of this Agreement.
16.2 Partial Invalidity
------------------
If any provision of this Agreement is held to be invalid, illegal, or
unenforceable by a court of competent jurisdiction, then: (a) such provision
will be deemed amended to conform to applicable laws of such jurisdiction so as
to be valid and enforceable, or, if it cannot be so amended without materially
altering the intention of the Parties, it will be stricken; (b) the validity,
legality and enforceability of such provision will not in any way be affected or
impaired thereby in any other jurisdiction; and (c) the remaining provisions of
this Agreement will remain in full force and effect.
16.3 Survival
--------
The covenants and agreements set forth in Articles 7, 11 and 13 shall survive
any termination or expiration of this Agreement and remain in full force and
effect regardless of the cause of termination.
16.4 Entire Agreement
----------------
This Agreement, including the attached Exhibits, constitutes the entire
agreement of the Parties with respect to the subject matter, and supersedes all
prior or contemporaneous understandings or agreements, whether written or oral,
between the Customer and INyX with respect to such subject matter. In
particular, (a) in the event of conflict between this Agreement and the terms
and conditions of any purchase order or other form generated in performance of
this Agreement, then the terms and conditions of this Agreement shall control,
and (b) in the event of conflict between this Agreement and the Quality
Agreement (as it may be amended from time to time), the terms of this Agreement
shall govern all aspects of the relationship between the Parties except that the
Quality Agreement shall govern with respect to quality matters.
16.5 Waivers
-------
No waiver of any term or condition of this Agreement shall be valid or binding
on either Party unless agreed in writing by the Party to be charged. The failure
of either Party to enforce at any time, or for any period of time, any provision
of this Agreement, or the failure to require at any time performance by the
other Party of any provision of this Agreement, shall in no way be construed to
be a present or future waiver of such provisions or of the right of such Party
thereafter to enforce that provision or other provisions of this Agreement.
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16.6 Assignment, Binding Effect
--------------------------
Neither Party shall assign this Agreement, by operation of law or otherwise,
except to an Affiliate of such Party, without the prior written consent of the
other Party, which consent shall not be unreasonably withheld, and any such
attempted assignment without such consent shall be void. No assignment shall be
effective until the assignee shall have unconditionally assumed in writing all
of the assignor's obligations under this Agreement and a written notice of such
assignment is given to all the other Parties. When duly assigned in accordance
with the foregoing, this Agreement shall be binding upon and inure to the
benefit of the assignee.
16.7 Amendment
---------
No amendment or modification of this Agreement shall be valid or binding upon
the Parties unless made in writing and signed by the duly authorized
representatives of both Parties.
16.8 Taxes
-----
INyX and the Customer shall cooperate in seeking and/or applying for all
available waivers, exclusions, exemptions, rebates and the like with respect to
potential taxes (e.g., VAT) on the Products.
16.9 Conflicting Terms and Conditions
--------------------------------
All sales under this Agreement shall be subject to the provisions of this
Agreement (including, without limitation, the Product Specifications) and shall
not be subject to the terms and conditions contained on any purchase order of
the Customer or confirmation of INyX, except insofar as any such purchase order
or confirmation establishes:
(a) the quantity and form of any Product ordered;
(b) the shipment date;
(c) the shipment routes and destinations; or
(d) the carrier.
16.10 Binding Effect and Assignment
-----------------------------
Each Party agrees that its rights and obligations under this Agreement may not
be transferred or assigned directly or indirectly, except as follows: (a) either
Party may transfer or assign this Agreement to an Affiliate of such Party which
agrees in writing to undertake the obligations under this Agreement, (b) either
Party may transfer or assign this Agreement in connection with the sale of all
or substantially all of the assigning Party's related business, and (c) either
Party may transfer or assign this Agreement to a non-Affiliate third party with
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CONFIDENTIAL TREATMENT
Page 27
the prior written consent of the other Party, which consent shall not be
unreasonably withheld. Subject to the foregoing, this Agreement shall be binding
upon and inure to, the benefit of the Parties, their successors and assigns. Any
attempted assignment contrary to the provisions of this Section 16.10 shall be
deemed ineffective, and either Party shall have the right to terminate this
Agreement, with the effect described in Section 10.2.
16.11 Counterparts
------------
This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original and all of which together shall constitute one and the
same agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed
by their respective duly authorized officers as of the date first written above.
XXXXXXX LABORATORIES, INC. INYX PHARMA LTD.
Per: /S/ Xxxxxx X. Xxxxxxx Per: /S/ Xxxxxx Xxxxxxx
------------------------ ---------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxxxx Xxxxxxx
Title: Vice President, Title: Director
CFO and Treasurer
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CONFIDENTIAL TREATMENT
Page 28
LIST OF EXHIBITS
Exhibit 4.3(a) Current Customers and Dermatological Products
Exhibit A Xxxxxxx Products
Exhibit B Pricing
Exhibit C Quality Agreement
Exhibit D Forecasts
Exhibit E-1, E-2 etc Development Agreements
Exhibit 4.3(a)
Current Customers and Dermatological Products
---------------------------------------------
See Attachment dated 28th February, 2003
Exhibit A
Xxxxxxx Products
----------------
Marketed Name NDC Code Size
Exhibit B
Pricing
-------
Name Size Price per Unit* Price per Unit(Free Issue)
* * *
Exhibit C
Quality Agreement
-----------------
[See Attachment dated 4.03.03]
Exhibit D
Forecast Format and Timing
--------------------------
With respect to forecasts supplied by the Customer:
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CONFIDENTIAL TREATMENT
Exhibits
Date Submitted Description Purchase Orders Issued
for Manufacturing Dates
During:
Exhibit E
Development Agreements
Future development agreements between the Parties with respect to new Product
candidates shall be attached to this Agreement as Exhibits E-1, E-2, E-3, etc.
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CONFIDENTIAL TREATMENT
Exhibits
